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Recall Observatory FDA recall evidence

Device product

Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL

Z-1478-2025

February 25, 2025

Class II

Product summary

Firm
Stryker Corporation
Event
Event 96393
Status
Ongoing
Classification
Class II
Quantity
182,344 total units
Official record key
device-enforcement:Z-1478-2025

Official wording

Reason: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

Code information: 5400-030-004 UDI-DI: 07613154340835, Lot Numbers: 2024052333 2023012514 2023050514 2023080912 2024020214; 5400-030-004ITL UDI-DI: 07613327359442, Lot Numbers: 2023071933 2023102714 2024012314

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.